NPI Engineer II — MedTech Cardio Devices

Shockwave Medical

Santa Clara (CA)

On-site

USD 87,000 - 140,000

Full time

14 days+

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Benefits offered by this job

Vacation time

Floating holidays

Parental Leave

Job summary

Johnson & Johnson is hiring an NPI Engineer II for the Santa Clara, CA site to drive process development for innovative peripheral, coronary, and heart valve devices. You will oversee pilot manufacturing/testing, support product transfers, and collaborate across R&D, operations, regulatory, and quality to bring products from development into production.

The role requires hands-on design and process validation capabilities, familiarity with Lean/Six Sigma, and experience in a fast-paced medical

Qualifications

Bachelor’s degree in Mechanical or Biomedical Engineering.
Min 3 years of experience in a medical device environment.
Knowledge of QA systems including FDA/ISO/MDR requirements.
Experience with Validation of Medical Devices (IQ-OQ-PQ).
Lean and Six Sigma concepts and statistics basics are a plus.

Responsibilities

Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
Identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
Coordinate and/or perform functional and destructive testing to support Engineering Reports with statistical analysis.
Participate in new product introduction, including scaling up, stabilizing and transfer to alternate sites.
Develop and maintain process FMEAs, MPIs, and DMR documents.
Create and release label files for product labels.
Create and execute process validation protocols and reports.
Support Quality System activities and CAPA/ NCR events.